Method and apparatus for closing off a portion of a heart ventricle

ABSTRACT

Apparatus and methods to reduce ventricular volume are disclosed. The device takes the form of a transventricular anchor, which presses a portion of the ventricular wall inward, thereby reducing the available volume of the ventricle. The anchor is deployed using a curved introducer that may be inserted into one ventricle, through the septum and into the opposite ventricle. Barbs or protrusions along the anchor body combined with a mechanical stop and a sealing member hold the device in place once deployed.

CROSS REFERENCE TO OTHER APPLICATIONS

This application claims the benefit of U.S. provisional application Ser.No. 60/689,012 filed Jun. 9, 2005, the disclosure of which is herebyincorporated by reference in its entirety.

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for temporarilyor permanently closing off a portion of the ventricle of the heart.

BACKGROUND OF THE INVENTION

In left ventricular hypertrophy, the myocardium of the left ventriclebecomes thickened to the point of interfering with effective heartcontraction. A surgical procedure for treating congestive heart failure,involves removing a triangular portion of a patient's heart. In thisoperation, approximately one-third of the patient's left ventricularmuscle is removed. The result is that the smaller heart pumps moreefficiently. This new technique of course requires open-heart surgery,with its attendant expense and extended convalescence.

One method to reduce ventricular volume is disclosed in U.S. Pat. No.6,776,754 to Wilk, which is hereby incorporated by reference in itsentirety.

For this and other potential procedures, it would be beneficial to havea method and system that could be temporarily and/or permanentlyimplanted to close off a portion of the ventricle.

SUMMARY OF THE INVENTION

The present invention relates to a catheter or surgical based systemcapable of closing off a portion of a ventricle of a patient. Theventricle may be temporarily blocked during a surgical procedure or itmay be permanently or semi-permanently closed off to improve cardiacfunction.

The present invention takes the form of an anchor for performing heartreconstruction including an elongated body, a plurality of protrusionsextending from the body, and first and second mechanical stops orsealing members attachable to the body.

The anchor of mechanical stop may include two or more folding arms. Thefolding arms may be pivotally attached to the first end of the body.

One end of the anchor may include a curved needle that forms one end ofthe anchor.

The anchor may be used with a curved introducer. The elongated bodybeing sized and configured to pass through the curved introducer.

The second sealing member may be held in place by a plurality ofprotrusions.

The sealing member may be formed of a resilient material.

A method of performing ventricular reconstruction, including the steps:(a) passing a curved needle through an anterior wall of a left ventricleof a patient; (b) passing the curved needle through the septum and intothe right ventricle; (c) inserting an anchor into the needle; (d)allowing one or more arms located on a distal end of said anchor todeploy; (e) removing the curved needle; (f) placing a sealing memberover a proximal end of said anchor; (g) folding a wall of the ventricleinward; (h) and using the sealing member to hold the folded wall inplace.

The method may include passing the curved needle through an anteriorwall of the right ventricle prior to step (d).

The method may be used to reduce the volume of the left ventricle and/orto treat left ventricular hypertrophy.

The method may include using the sealing member to hold the wall of theventricle in place by engaging one or more protrusions extending fromthe anchor.

The method using a sealing member formed of a resilient material, suchthat the sealing member is resiliently deformed, thereby resilientlypressing against the wall of the ventricle.

The method may include the step of removing a portion of the anchorafter the wall of the ventricle has been moved.

The method may be used to temporarily or permanently implant the device.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1C show a method and device for left ventricular reconstructionusing a left ventricular approach.

FIGS. 2A-C show an alternate procedure of FIGS. 1A-C.

FIGS. 3A-B show a method and device for left ventricular reconstructionusing a right ventricular approach.

DETAILED DESCRIPTION

FIGS. 1A-1C show a method and device 100 for left ventricularreconstruction using a left ventricular approach. The device is ananchor deployment system 100, which is guided to the correct location onthe heart by introducing a hollow curved introducer or needle 102 inthrough the anterior wall of the left ventricle. A visual guidancesystem, such as TEE, may be used to ensure the placement accuracy. Thetip of the curved needle 102 is then guided through the septum and intothe right ventricle. Either before placement or once the needle 102 isin place, the transventricular anchor 104 is loaded into the needle 102.The distal tip of the anchor 104 is extended into the cavity of theright ventricle.

The distal tip of the anchor 104 has a mechanical stop 106. Although itmay take any suitable form, such as a resilient member or mechanicaldevice, in the embodiment shown, the stop 106 has two or more pivotingarms 108. While the anchor 104 is within the needle 102, the arms 108are held close to the body of the anchor 104. When the distal tip of theanchor 104 extends beyond the distal tip of the needle 102, the arms 108are free to open. The arms 108 may be biased toward the open position orthey maybe be manually opened. Once opened, the arms 108 prevent thedistal end of the anchor 104 from passing back through the opening inthe septum.

After the anchor 104 is in place, the needle 102 may be removed. Aproximal sealing lock 110 is then slid onto the proximal end of theanchor 104. The sealing lock 110 is slid along the body and over one ormore barbs 112 or other protrusions extending from the body of theanchor 104. The barbs 112 may take any suitable form, such as rounded ortriangular. In the embodiment shown, the barbs 112 are generallytriangular in shape. The proximal sealing lock 110 is advance until theanterior wall of the left ventricle is pressed inward, thereby foldingthe wall and reducing the interior volume of the left ventricle. Oncethe sealing lock 110 is advanced into place, the proximal portion of thebody of the anchor 104 may be trimmed or cut off. Although the sealinglock 110 may be formed of any suitable material, the sealing lock 110shown is made of a resilient material to allow it open and be compressedagainst the heart tissue. The resilience of the material providesbenefits both in helping to seal the opening created as well hasresiliently holding the wall of the ventricle in the modifiedconfiguration.

In alternate embodiments, an adhesive, bonding or other mechanical orchemical means may be used to connect the sealing lock 110 to the anchor104.

If desired, the tip of the hollow needle 102 may be equipped with apressure sensor to guide the practitioner to know if the tip is in theleft ventricle, septum or the right ventricle by sensing the pressure.The hollow needle 102 may also be equipped with electrical sensor (EKG,Monophasic Action Potential) to sense if the puncture sight is theviable tissue or infarcted tissue.

FIGS. 2A-C show an alternate procedure of that shown in FIGS. 1A-C. Inthis method, the distal end of the anchor is again guided to theanterior wall of the left ventricle. The tip of the curved needle 102 isthen guided through the septum and into the right ventricle. In theconfiguration shown in FIG. 2A, the introducer 102 also extends throughthe anterior wall of the right ventricle. Once deployed, the distal tipof the anchor 104 is outside the right ventricle and the proximal tip isoutside the left ventricle.

FIGS. 3A-B show a method and device for left ventricular reconstruction120 using a right ventricular approach. In this version, a curved needle122 forms the distal tip of the anchor. The curved needle 122 isinserted through the anterior wall and into the right ventricle, throughthe septum, and through the anterior wall of the left ventricle. Thebody of the anchor follows the curved needle 122 and is fed throughuntil the proximal stop 124 engages the anterior surface of the rightventricle. The anterior wall of the left ventricle is pressed inwardover the body of the anchor. A distal sealing stop 126 is threaded overthe anchor 120 and slid in place against the anterior surface of theright ventricle. The heart tissue may be pressed inward to fold the wallof the heart prior to the placement of the sealing stop 126 or thesealing stop 126 may be used to manipulate the heart tissue. A pluralityof barbs or protrusions 128 extend from the surface of the anchor body.The barbs 128 help hold the heart tissue in place. The curved needle 122and the excess portion of the distal end of the anchor may be removed.This may be done before or after the distal sealing stop 126 has beenplaced.

The transventricular anchor may be temporarily or permanently implanted.A temporary implantation may be beneficial to test the effectiveness ofthe treatment for a particular patient. Other surgical procedures mayonly require a temporary reduction in ventricle volume. For thesesituations, the device may be removable. To remove the device, it may becut or broken or another release mechanism may be used to allow forremoval of the device. Once the efficacy is confirmed for a patient, apermanent version of the anchor could be implanted. Alternately, asemi-permanent or permanent device may be implanted initially.

The transventricular anchor may be used to treat medical conditionsincluding left ventricular hypertrophy. While the examples given arespecific to performance of reconfiguration of the left ventricle. Otherprocedures could also be performed to reduce the internal volume ofother bodily structures, including other chambers of the heart, gastricsystem, etc.

The present invention may be deployed during an open-heart procedure orit may be done using minimally invasive techniques using cathetersystems and/or ports formed between the ribs.

Many features have been listed with particular configurations, options,and embodiments. Any one or more of the features described may be addedto or combined with any of the other embodiments or other standarddevices to create alternate combinations and embodiments.

Although the invention has been fully described above, in relation tovarious exemplary embodiments, various additions or other changes may bemade to the described embodiments without departing from the scope ofthe present invention. Thus, the foregoing description has been providedfor exemplary purposes only and should not be interpreted to limit thescope of the invention.

1. A method of performing ventricular reconstruction of a heart, themethod comprising the steps of: (a) passing a curved needle from outsidethe heart through an anterior wall of a left ventricle of a patient toform a perforation of the anterior wall, the curved needle having acurvature; (b) passing the curved needle from the perforation of theanterior wall through the septum and into the right ventricle to form aperforation of the septum, the perforation of the septum being offsetfrom the perforation of the perforation of the anterior wallcorresponding with the curvature of the curved needle; (c) inserting adistal end of an anchor through the perforation of the anterior wall andthrough the perforation of the septum formed by the needle; (d) allowingone or more arms located on the distal end of said anchor to deploywhile an elongate proximal end of the anchor extends through theperforation of the anterior wall and through the perforation of theseptum; (e) removing the curved needle; (f) placing a sealing memberover the proximal end of said anchor; (g) folding a wall of theventricle inward; and (h) holding the folded wall in place using thesealing member so that the anterior wall sealingly engages the septumalong the fold and a portion of the ventricle is closed off.
 2. Themethod of claim 1, further comprising the step of passing the curvedneedle through an anterior wall of the right ventricle prior to step(d).
 3. The method of claim 1, wherein (g) folding the wall of theventricle inward and (h) holding the folded wall in place reduces thevolume of the left ventricle.
 4. The method of claim 1, wherein theventricular reconstruction is performed to treat left ventricularhypertrophy.
 5. The method of claim 1, wherein the sealing member holdsthe anterior wall in place by engaging one or more protrusions extendingfrom the elongate proximal end of the anchor.
 6. The method of claim 1,wherein the sealing member comprises a resilient material adapted toresiliently press against the wall of the ventricle.
 7. The method ofclaim 1, further comprising removing a portion of the elongate proximalend of the anchor after the step of (g) folding the wall of theventricle inward.
 8. The method of claim 1, wherein the anchor istemporarily implanted.
 9. The method of claim 1, wherein the anchor ispermanently implanted.
 10. The method of claim 1, wherein the one ormore arms are pivotally deployed.
 11. The method of claim 1, wherein thecurved needle comprises a hollow bore and the step of (c) inserting thedistal end of the anchor through perforation of the anterior wall andthrough the perforation of the septum formed by the needle comprisesinserting the distal end of the anchor into the hollow bore of thecurved needle.
 12. The method of claim 1 further comprising passing thecurved needle through an anterior wall of the right ventricle to form aperforation of the right ventricular anterior wall.
 13. The method ofclaim 12, wherein inserting the anchor through the perforation of theleft ventricular anterior wall and through the perforation of the septumcomprises inserting the anchor through the perforation of the rightventricular anterior wall, through the perforation of the septum, andthrough the perforation of the left ventricular anterior wall.
 14. Themethod of claim 1, further comprising sensing pressure near a tip of thecurved needle during the passing of the curved needle so as to determineif the tip is disposed in a ventricle.
 15. The method of claim 1,further comprising guiding the passing of the curved needle withreference to echographic images.
 16. A method of performing ventricularreconstruction of a heart, the method comprising: passing a curvedneedle from outside the heart through an anterior wall of the leftventricle to form a perforation of the left ventricular anterior wall,the curved needle having a curvature; passing the curved needle from theperforation of the anterior wall through the septum and into the rightventricle to form a perforation of the septum, the perforation of theseptum being offset from the perforation of the anterior wallcorresponding with the curvature of the curved needle; inserting ananchor through the perforation of the left ventricular anterior wall andthrough the perforation of the septum; allowing one or more arms of theanchor to deploy while an elongate end of the anchor extends through theperforation of the anterior wall and through the perforation of theseptum; removing the curved needle; placing a sealing member over theelongate end of the anchor; folding a wall of the left ventricle inward;and holding the folded wall in place using the sealing member so thatthe anterior wall sealingly engages the septum along the fold and aportion of the left ventricle is closed off.
 17. The method of claim 16,wherein the curved needle is coupled to a distal end of the anchor. 18.The method of claim 17, wherein inserting the anchor through theperforation of the left ventricular anterior wall and through theperforation of the septum comprises inserting the distal end of theanchor through the perforation of the left ventricular anterior wall andthrough the perforation of the septum.
 19. The method of claim 17,wherein removing the curved needle comprises removing the curved needlefrom the distal end of the anchor.
 20. The method of claim 16, whereinthe elongate end of the anchor comprises an elongate proximal end of theanchor, and the one or more arms of the anchor are disposed on theproximal end.
 21. The method of claim 16, wherein placing the sealingmember over the anchor comprises placing the sealing member over adistal end of the anchor.
 22. The method of claim 16, further comprisingremoving a portion of the elongate end of the anchor after folding thewall of the ventricle inward.
 23. The method of claim 16, wherein theone or more arms are pivotally deployed.
 24. The method of claim 16,further comprising sensing pressure near a tip of the curved needleduring the passing of the curved needle so as to determine if the tip isdisposed in a ventricle.
 25. The method of claim 16, further comprisingguiding the passing of the curved needle with reference to echographicimages.